Tofacitinib Citrate residual solvent GC detection method

A technology of tofacitinib and its detection method, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve problems such as the inability to determine the specific content and the determination of solvent residues, and achieve the effects of high accuracy, simple detection method, and high sensitivity

Inactive Publication Date: 2019-09-27
NANJING GRITPHARMA CO LTD
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Problems solved by technology

According to the existing literature, there is no way to measur

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  • Tofacitinib Citrate residual solvent GC detection method
  • Tofacitinib Citrate residual solvent GC detection method

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Embodiment 1

[0034] (1) Instrument and chromatographic conditions

[0035] Gas chromatograph: Agilent gas chromatograph and U3000 workstation;

[0036] Chromatographic column: DIKMA DM-35 (30m×0.53mm, 1 μm) capillary column with 35% ditetrahydropyrrolyl-65% dimethylpolysiloxane as the stationary phase.

[0037] The temperature was programmed, the initial temperature was 45°C, maintained for 1 minute, raised to 140°C at a rate of 5°C per minute, and then raised to 200°C at a rate of 30°C per minute, maintained for 3 minutes. Detector FID, temperature 200°C, inlet temperature 200°C, split ratio 20:1, flow rate 1.0ml / min, carrier gas nitrogen.

[0038] (2) Experimental steps

[0039] Take an appropriate amount of ethanol, acetone, and DMSO respectively, and use the solvent N,N-dimethylformamide to make a mixed solution containing 125 μg of each solvent per ml as the analysis solution;

[0040] Take 1 μl of the above analysis solution, inject it into the gas chromatograph, and record the ch...

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Abstract

The invention relates to the technical field of drug analysis, in particular to a gas-liquid chromatography detection method of a tofacitinib citrate residual solvent. The method comprises the following steps of: configuring an analysis solution; setting chromatographic conditions; and performing determination on a machine. The method can effectively determine the content of the tofacitinib citrate residual solvent, thereby ensuring the controllable quality of the product.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a gas-liquid chromatography detection method for tofacitinib citrate residual solvents. Background technique [0002] The so-called "residual solvent" in drug analysis refers to the organic solvent used in the production process of raw materials or excipients, as well as in the preparation of preparations, but not completely removed in the process. The selection of a suitable solvent in the synthesis of raw materials is an essential key factor in the synthesis process, which can improve the yield and determine the properties of the drug, such as crystal form, purity, dissolution rate, etc. Residual solvents are an important class of impurities in drugs. They are toxic or carcinogenic. When the level is higher than the safe value, they will cause harm to the human body or the environment. Therefore, the detection of residual solvents in drugs is an important part of drug qua...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 朱敏熊汝菊陆滢炎吴小涛赵卿霍立茹李战
Owner NANJING GRITPHARMA CO LTD
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